Alexander Provision in FDA Bill Makes Medicines and Medical Devices Safer For Children

Says “new critically important resources will help the FDA bring new products more quickly to Americans who need them”

Posted on May 23, 2012


“Our legislation helps combat prescription drug abuse. Tennessee ranks second in the nation for prescription drug use. Our governor, Bill Haslam, and our legislature took action this year to deal with that. We intend to help them.” – Lamar Alexander


WASHINGTON – In a speech on the floor of the Senate Tuesday, U.S. Senator Lamar Alexander (R-Tenn.), a member of the Senate Health, Education and Labor Committee, urged quick passage this week of the Food and Drug Administration Safety and Innovation Act, which he helped draft in committee, saying it is “a piece of legislation that affects every American family.”


Alexander detailed several things the legislation would do:


  • “It reauthorizes two user fee programs. These things have absurd names---like the Prescription Drug User Fee Act is called PDUFA and the Medical Device User Fee Modernization Act is Called MDUFMA, and there are two new ones called GDUFA and BSUFA…but they’re critically important programs that give the Food and Drug Administration needed resources to review new medically necessary products.”


  • “It will give the FDA additional tools to help prevent drug shortages and require the FDA to look internally at regulations to see if the FDA is making the problem worse.”


  • “This makes permanent the Best Pharmaceuticals for Children Act and reauthorizes the Pediatric Research Equity Act. One is an incentive and one requires pharmaceutical companies under certain circumstances, when they develop new drugs for adults, to figure out the effect that those drugs will have on children. Too often we don't know the answer to that, and the drugs are either ineffective or can have bad results. This is a very important part of the bill.”
  • “Another critical part of the bill has to do with the medical device approval process. The United States is a world leader in medical devices. In Tennessee we have lots of them, especially in Memphis. We need to improve the regulatory process. There are many who believe the FDA is over-regulating medical devices. That has a negative effect on the industry's ability to raise capital and create jobs. It does not make those devices any safer in the United States than they are in Europe. This will help address those problems.


  • “Senator [Bob] Casey and I worked together on a review of Federal initiatives to combat prescription drug abuse and to issue a report on those. Tennessee, my State, ranks second in the Nation for prescription drug use. Our Governor, Bill Haslam, and our legislature took action this year to deal with that. We intend to help them.”



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